Data-enabled pharmaceutical container and methods for using same

ABSTRACT

A data-enabled pharmaceutical container and methods for reminding at dose time, then tracking and communicating valid dose events and/or dose exception events are disclosed. Examples of dose exception events include, but are not limited to, missed doses, extra doses, early doses, and late doses. The data-enabled pharmaceutical container includes control electronics for processing and communicating information about valid dose events and/or dose exception events. For example, using a dose detection algorithm, a dose event is deemed valid based on (1) sensing the open state of the data-enabled pharmaceutical container (e.g., sensing that the closure is not present), (2) sensing a certain orientation or tilt of the data-enabled pharmaceutical container, and (3) sensing that the data-enabled pharmaceutical container is both opened and tilted simultaneously for a certain amount of time (e.g., a few seconds).

RELATED PATENTS

This patent application is a divisional of, claims priority to, andincorporates by reference U.S. patent application Ser. No. 14/042,767,filed Oct. 1, 2013, entitled “Data-Enabled Pharmaceutical Container andMethods for Using Same.”

This application is also related to U.S. Pat. No. 8,067,935, filed Jun.5, 2008, entitled “System for sensing the opening and closing of apharmaceutical container,” which is incorporated by reference herein inits entirety.

FIELD OF THE INVENTION

The present invention generally relates to the field of medicationadherence. In particular, the present invention is directed to adata-enabled pharmaceutical container and methods for reminding at dosetime, then tracking and communicating valid dose events and/or doseexception events.

BACKGROUND

Outpatient prescription medication treatments are relied upon heavilyfor increased quality of life and lower lifetime healthcare costs.Medical experts have long held that taking at least 80% of a prescribeddrug is required to achieve desired therapeutic outcomes and lowerlifetime healthcare costs. For example, a patient who faithfully takescholesterol-reducing medicine significantly reduces the likelihood of acoronary event that has attendant cost-intensive medical procedures anddiminished quality of life. Outpatients strongly desire to avoid suchevents and hospital stays, yet only 20% of all outpatients take theirprescription medicines according to doctor's instructions.

Increased medication adherence, also known as patient adherence,medication compliance, or patient compliance, benefits the healthcaresystem by vastly reducing patients' lifetime medical costs whileincreasing their therapeutic outcomes. Further, market research suggeststhat patients have a desire to comply, but will not take on the burdenof any additional actions or otherwise change their behavior.

SUMMARY OF THE INVENTION

In one embodiment, the invention provides a data-enabled pharmaceuticalcontainer. The data-enabled pharmaceutical container may include apharmaceutical container; and an electronics module configured forsensing and tracking dose events coupled to the pharmaceuticalcontainer. The pharmaceutical container may include a container body; acontainer neck; and a container closure, wherein the container body maybe configured as a reservoir for holding a quantity of medication, thecontainer neck may include an opening for dispensing the medication fromthe container body, and the container closure may be configured tosecure the container neck opening. The medication may include pills,capsules, or caplets. The electronics module may include a housing and aprinted circuit board (PCB) assembly housed therein, the PCB assemblymay include a PCB; one or more indicators, one or more switches; and oneor more sensors. The one or more sensors may include active and/orpassive sensors. At least one of the sensors may be configured to senseone or more of a presence or absence of the container closure and anorientation or tilt of the pharmaceutical container. The electronicsmodule may further include electrical components for processing datafrom the sensors with respect to a patient's predefined dosing regimen,and for storing and communicating data about doses taken, doses missed,extra doses, early doses, and/or late doses. The one of the one or moresensors may include a movable lever. The movable lever may extendthrough an opening in the housing and toward the container neck, whereinthe movable lever may be part of a mechanism for sensing whether thecontainer closure is present at or absent from the container neck. Themovable lever may be configured such that when the container closure ispresent on the container neck an edge of the container closure is incontact with a tip of the movable lever causing the movable lever to bein a first position, and when the container closure is not present onthe container neck the edge of the container closure does not contactthe tip of the movable lever causing the movable lever to be in a secondposition. The one or more switches of the PCB assembly may include amomentary contact switch and wherein the movable lever in one of thefirst and second positions engages an actuator of the momentary contactswitch. The container of movable lever and the momentary contact switchmay provide the sensing mechanism for determining whether the containerclosure of pharmaceutical container is in an opened or closed state,wherein when the container closure is present and in contact with thetip of the movable lever, a portion of the movable lever is pushedagainst the actuator of the momentary contact switch, and the momentarycontact switch is in one state, and when the container closure is notpresent and not in contact with the tip of the movable lever, themovable lever is not pushed against the actuator of the momentarycontact switch, and the momentary contact switch is in another state.The electronics module may be coupled to the pharmaceutical container,such that there is no contact between the electronics module and themedication therein. The electronics module may be coupled to thecontainer body using a sleeve, wherein the sleeve may affix theelectronics module to the container body. The pharmaceutical containermay include an integrated pharmaceutical container, wherein thepharmaceutical container comprises a compartment for housing theelectronics module. The pharmaceutical container may further include abattery compartment. The electronics module may include controlelectronics including a communications interface; a processor; areal-time clock; a contact switch; a tilt sensor; and the one or moreindicators. The processor may include data storage for storing one ormore of a patient's dosing regimen; a dose detection algorithm; andactual dose data. The control electronics may be configured forproviding a reminder at dose time, detecting valid dose events, andprocessing and communicating data about dose events and/or doseexception events. The at least one of the sensors may include a tiltsensor. The tilt sensor senses when the container body is in a tiltedstate exceeding a threshold angle from a first position. The thresholdangle may be in the range of about 45° to about 90°. The tilt sensor mayinclude any one of an on/off tilt sensor, an accelerometer, an inertialmeasurement unit (IMU), or an inclinometer. The sensing a valid doseevent may require data input from at least two of the one or moreswitches and/or sensors to coincide with one another. The coinciding atleast two data inputs from the one or more switches and/or sensors mayinclude data input indicating the container closure is not present onthe container neck and the container body is in a tilted state exceedinga threshold angle from a first position. The one or more indicators mayinclude light-emitting diodes (LED). The electronics module may befurther configured for providing a dose reminder and communicating validdose events and/or dose exception events.

In another embodiment, the invention provides a method of determining avalid dose event using a data-enabled pharmaceutical container. Themethod may include providing a data-enabled pharmaceutical container;monitoring the data-enabled pharmaceutical container for pre-definedvalid dose event criteria; determining whether the data-enabledpharmaceutical container has met the pre-defined criteria for the validdose event; and recording the valid dose event upon determining thepre-defined criteria for the valid dose event is met. The data-enabledpharmaceutical container, may include a pharmaceutical container; and anelectronics module configured for sensing and tracking dose eventscoupled to the pharmaceutical container, wherein the pharmaceuticalcontainer may include a container body; a container neck; and acontainer closure, wherein the container body may be configured as areservoir for holding a quantity of medication, the container neckcomprises an opening for dispensing the medication from the containerbody, and the container closure may be configured to secure thecontainer neck opening, and wherein the electronics module may include ahousing and a printed circuit board (PCB) assembly housed therein, thePCB assembly may include a PCB; one or more indicators, one or moreswitches; and one or more sensors. The determining of whether thedata-enabled pharmaceutical container has met the pre-defined criteriafor the valid dose event may include one or more of determining if thedata-enabled pharmaceutical container is in an opened state, determiningwhether the data-enabled pharmaceutical container has met a defined tiltcriteria, and determining whether the data-enabled pharmaceutical hasmet a defined time criteria. The pre-defined criterion for the validdose event may include the data-enabled pharmaceutical container beingin an opened state and the data-enabled pharmaceutical containerexceeding a defined tilt threshold criterion for a defined period oftime. The method may further include detecting, tracking, andcommunicating data regarding valid dose events and/or dose exceptionevents. The monitoring of the data-enabled pharmaceutical container forpre-defined valid dose event criteria may include, the electronicsmodule continuously monitoring the state of the one or more switches andsensors, and time of a real-time clock in relation to a patient'sdefined dosing regimen. The method may further include detecting,tracking, and communicating data regarding a patient's actual doseinformation.

In yet another embodiment, the invention provides a method of using adata-enabled pharmaceutical container for reminding at dose time, thentracking and communicating valid dose events and/or dose exceptionevents. The method may include preparing the data-enabled pharmaceuticalcontainer for use; monitoring valid dose event criteria and medicationadherence; determining whether a valid dose event has occurred; andrecording actual dose event data. The preparing of the data-enabledpharmaceutical container for use may include one or more of programminga patient's dosing regimen into a processor of the data-enabledpharmaceutical container; loading updates into the processor of thedata-enabled pharmaceutical container; retrieving stored dose eventdata; setting or resetting a real-time clock of the data-enabledpharmaceutical container; checking diagnostics of the data-enabledpharmaceutical container; filling the data-enabled pharmaceuticalcontainer with medication; and labeling the data-enabled pharmaceuticalcontainer. The monitoring of valid dose event criteria and medicationadherence may include the processor receiving and interpreting data fromone or more of the patient's dosing regimen; a dose detection algorithm;the real-time clock; whether and when valid dose events occur andwhether they are in compliance with/adherent to dosing instructionsstored in the patient's dosing regimen. The data-enabled pharmaceuticalcontainer may include one or more indicators capable of being monitoredby the patient. The one or more indicators may be one or more of visualand audible. The one or more indicators may be configured to indicate tothe patient at least one of, time to take a dose, a dose has beenmissed, and time for a prescription refill. The method may furtherinclude transmitting data from the data-enabled pharmaceutical containerto an external computing device using a communications interface. Themethod may further include following an actual dose event, deactivatingany previously activated indicators and activating an applicableindicator according to the patient's dosing regimen and recording theactual dose event data. The data from the data-enabled pharmaceuticalcontainer may be transmitted to one or more of the patient, caretaker,and an authorized party via the communications interface. If therecorded actual dose event is a missed dose event according to thepatient's dosing regimen the one or more indicators indicate a misseddose, and if the recorded actual dose event is a valid dose eventaccording to the patient's dosing regimen the one or more indicatorsindicate a taken dose, and the applicable actual dose event is recorded.The method may further include determining whether a prescription refillis needed based on a number of valid dose events as compared to therecorded actual dose data and the patient's dosing regimen. If it isdetermined a prescription refill is needed the one or more indicatorsmay indicate a prescription refill is needed. A prescription refillnotice may be sent to one or more of the patient, a pharmacy, and anyother caretaker or authorized party via a communications interface.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus described the presently disclosed subject matter in generalterms, reference will now be made to the accompanying Drawings, whichare not necessarily drawn to scale, and wherein:

FIG. 1, FIG. 2, and FIG. 3 illustrate perspective views of adata-enabled pharmaceutical container for reminding at dose time, thentracking and communicating valid dose events and/or dose exceptionevents;

FIG. 4 illustrates a perspective view of an electronics module of thepresently disclosed data-enabled pharmaceutical container;

FIG. 5 and FIG. 6 illustrate perspective views of other examples of thepresently disclosed data-enabled pharmaceutical container;

FIG. 7 illustrates a perspective view of an example of the presentlydisclosed data-enabled pharmaceutical container that includes anintegrated pharmaceutical container;

FIG. 8 illustrates a block diagram of an example of control electronicsof the presently disclosed data-enabled pharmaceutical container;

FIG. 9 and FIG. 10 illustrate plan views of the side of a PCB assemblyof the presently disclosed data-enabled pharmaceutical container,wherein the PCB assembly is oriented toward the container body andshowing a lever thereof in two different positions, respectively;

FIG. 11 illustrates a plan view of the side of the PCB assembly of thepresently disclosed data-enabled pharmaceutical container, wherein thePCB assembly is oriented away from the container body;

FIG. 12A and FIG. 12B illustrate a perspective view and a back view,respectively, of an example of the lever of the presently discloseddata-enabled pharmaceutical container;

FIG. 13 illustrates a flow diagram of an example of a method ofdetermining a valid dose event using the presently discloseddata-enabled pharmaceutical container;

FIG. 14 illustrates a flow diagram of an example of a method ofoperation of the presently disclosed data-enabled pharmaceuticalcontainer; and

FIG. 15 and FIG. 16 are perspective views and an example of adata-enabled pharmaceutical sleeve into which a conventionalpharmaceutical container is installed, wherein together the data-enabledpharmaceutical sleeve and the conventional pharmaceutical containerprovide substantially the same functionality as the presently discloseddata-enabled pharmaceutical container.

DETAILED DESCRIPTION

The presently disclosed subject matter provides a data-enabledpharmaceutical container and methods for reminding at dose time, thentracking and communicating valid dose events and/or dose exceptionevents. Examples of dose exception events include, but are not limitedto, missed doses, extra doses, early doses, and late doses. In someembodiments, the presently disclosed subject matter provides anelectronics module that can be attached to any conventionalpharmaceutical container, thereby forming the data-enabledpharmaceutical container. In other embodiments, the data-enabledpharmaceutical container is formed of a custom pharmaceutical containerin which the electronics is built directly into the container. Namely,the custom pharmaceutical container includes one compartment for holdingmedication and another compartment for housing the electronics, whereinthe electronics is not in contact with the contents of the container.

The presently disclosed subject matter also provides a data-enabledpharmaceutical sleeve into which a conventional pharmaceutical containeris installed, wherein the sleeve includes the electronics. Together, thedata-enabled pharmaceutical sleeve and the conventional pharmaceuticalcontainer provide substantially the same functionality as thedata-enabled pharmaceutical container.

The electronics module of the data-enabled pharmaceutical containerincludes circuitry for reminding at dose time, then detecting valid doseevents, as well as for processing and communicating information aboutvalid dose events and/or dose exception events. For example, using adose detection algorithm, a dose event is deemed valid based on (1)sensing the open state of the data-enabled pharmaceutical container(e.g., sensing that the closure is not present), (2) sensing a certainorientation or tilt (e.g., more than 90 degrees from vertical, or pasthorizontal) of the data-enabled pharmaceutical container, and (3)sensing that the data-enabled pharmaceutical container is both openedand tilted more than 90 degrees simultaneously for a certain amount oftime (e.g., a few seconds).

An aspect of the data-enabled pharmaceutical container is that it may beused to increase patient adherence with respect to dosing regimens whilerequiring no additional actions or otherwise changed behavior by thepatient, such as programming, record keeping, or decanting of medicationfrom one container into another.

Another aspect of the data-enabled pharmaceutical container is that thesensing mechanisms are reliable and are sufficiently low cost to bepractical for use in commercial product applications.

Yet another aspect of the data-enabled pharmaceutical container is thatrecords of digital information about dose events and/or dose exceptionevents (e.g., missed, extra, early, and late doses) are automaticallygenerated and stored thereon, wherein the digital information can beused to determine periodically or continuously whether the prescribeddosing regimen is being followed.

Still another aspect of the data-enabled pharmaceutical container isthat it includes a communications interface for wired or wirelesscommunication with an external computing device.

FIG. 1, FIG. 2, and FIG. 3 illustrate perspective views of adata-enabled pharmaceutical container 100 for reminding at dose time,then tracking and communicating valid dose events and/or dose exceptionevents. The data-enabled pharmaceutical container 100 includes anelectronics module 110 that is attached or otherwise affixed to apharmaceutical container 150. The pharmaceutical container 150 can besubstantially any pharmaceutical container in use today. In the exampleshown in FIG. 1, FIG. 2, and FIG. 3, the pharmaceutical container 150includes a container body 152 and a container neck 154. The containerbody 152 is a reservoir for holding, for example, a quantity of pills,capsules, caplets, and the like, which, for example, are prescribed to apatient (not shown) according to a certain dosing regimen. The containerneck 154 is the opening for dispensing medication from the containerbody 152. In one example, the container neck 154 may be threaded forreceiving a closure 156, which may be a screw-type cap. Thepharmaceutical container 150 (e.g., the container body 152, thecontainer neck 154, and the closure 156) may be formed of any suitablyrigid, lightweight, and food-safe material, such as molded high-densitypolyethylene (HDPE), e.g., molded plastic. Other examples of thepharmaceutical container 150 are shown with reference to FIG. 5 and FIG.6.

The electronics module 110 may include active and passive electricalcomponents for sensing the presence or absence of the closure 156, forsensing the orientation or tilt of the pharmaceutical container 150, forprocessing these sensing mechanisms with respect to the patient's dosingregimen, and for storing and communicating information about dosestaken, doses missed, extra doses, early doses, and/or late doses. Moredetails of the electronics module 110 are shown and described withreference to FIG. 4 and FIG. 8.

Referring now to FIG. 1, the data-enabled pharmaceutical container 100is shown with the electronics module 110 apart from the pharmaceuticalcontainer 150, e.g., prior to assembly. Referring now to FIG. 2 and FIG.3, the data-enabled pharmaceutical container 100 is shown with theelectronics module 110 attached to the pharmaceutical container 150,e.g., after assembly. In FIG. 1, FIG. 2, and FIG. 3, the pharmaceuticalcontainer 150 may be a container that has a substantially square orrectangular cross-section. Therefore, the housing of the electronicsmodule 110 may be attached to one side of the pharmaceutical container150, which may be flat. FIG. 2 shows the data-enabled pharmaceuticalcontainer 100 in the closed state, meaning that the closure 156 may besecured atop the container neck 154 of the container body 152. Bycontrast, FIG. 3 shows the data-enabled pharmaceutical container 100 inthe opened state, meaning that the closure 156 is not secured atop thecontainer neck 154 of the container body 152.

Additionally, FIG. 3 and FIG. 4 show more details of the physicalinstantiation of the electronics module 110. For example, theelectronics module 110 includes a printed circuit board (PCB) assembly112 that may be enclosed in a housing 114, wherein the shape and size ofthe housing 114 can vary according to the shape and size of thepharmaceutical container 150. The housing 114 can be formed, forexample, of the same material that the pharmaceutical container 150 isformed of (e.g., molded plastic). The PCB assembly 112 further includesa PCB 116 on which the control electronics (see FIG. 8) is implemented,a movable lever 118, one or more of the indicators 120, and variousother switches and sensors (again see FIG. 8).

The lever 118 extends through an opening in the housing 114 and towardthe container neck 154 as shown. The lever 118 is part of the mechanismfor sensing whether the closure 156 is present at or absent from thecontainer neck 154, meaning whether the data-enabled pharmaceuticalcontainer 100 is closed or opened. Namely, when the closure 156 ispresent (e.g., when the data-enabled pharmaceutical container 100 isclosed) the edge of the closure 156 comes into contact with the tip ofthe lever 118, which causes the lever 118 to be in one position.However, when the closure 156 is not present (e.g., when thedata-enabled pharmaceutical container 100 is opened) the edge of theclosure 156 is not in contact with the tip of the lever 118, whichcauses the lever 118 to be in a different position. The lever 118 isused in conjunction with a momentary contact switch (see FIG. 8). Moredetails of the lever 118 are shown and described with reference to FIG.9 through FIG. 12D.

The housing 114 and the PCB assembly 112 are provided on the outside ofthe container body 152, such that there is no contact with the contentsinside of the container body 152. In one example, the housing 114 andthe PCB assembly 112 are affixed to the container body 152 using asleeve or label 158, wherein the sleeve or label 158 is wrapped aroundboth the container body 152 and the housing 114 so that the housing 114is substantially hidden from view. The sleeve or label 158 is formed ofany material suitable to be printed on and suitable to last the lifetimeof the data-enabled pharmaceutical container 100.

The pharmaceutical container 150 of the data-enabled pharmaceuticalcontainer 100 is not limited to a four-sided type of container with athreaded neck and threaded cap. Any type of pharmaceutical container canbe used in the data-enabled pharmaceutical container 100. FIG. 5 showsanother example of a pharmaceutical container 150 in which the containerbody 152 has a cylindrical shape and in which the closure 156 is asnap-fitted cap. In this example, the housing 114, the PCB assembly 112,and the lever 118 are sized and shaped accordingly such that thesnap-fitted the closure 156 can be in contact with the tip of the lever118 when the snap-fitted the closure 156 is present (e.g., when thedata-enabled pharmaceutical container 100 is closed). FIG. 6 shows yetanother example of a pharmaceutical container 150 that is substantiallythe same as the Pharmaceutical container 150 shown in FIG. 1, FIG. 2,and FIG. 3 except that the container body 152 is cylindrical rather thanfour-sided. Again, the housing 114, the PCB assembly 112, and the lever118 are sized and shaped accordingly and such that the screw-typeclosure 156 can be in contact with the tip of the lever 118 when thescrew-type closure 156 is present (e.g., when the data-enabledpharmaceutical container 100 is closed).

In another embodiment of the data-enabled pharmaceutical container 100,instead of using a separate electronics module 110 with an existingpharmaceutical container 150, the data-enabled pharmaceutical container100 can include a customized container that includes at least a firstcompartment for holding medication and a second compartment for housingthe PCB assembly 112, wherein the PCB assembly 112 is not in contactwith the medication in the first compartment. For example, FIG. 7 showsan example of the data-enabled pharmaceutical container 100 thatincludes an integrated pharmaceutical container 710. The integratedpharmaceutical container 710 includes a medication compartment 712, anelectronics compartment 714, and optionally a battery compartment 716.

The medication compartment 712 is a reservoir for holding, for example,a quantity of pills, capsules, caplets, and the like, which areprescribed to a patient (not shown) according to a certain dosingregimen. Atop the medication compartment 712 is a container neck 718,which is the opening for dispensing medication from the medicationcompartment 712. In this example, the container neck 718 is threaded forreceiving a closure 720, which is a screw-type cap. The integratedpharmaceutical container 710 may be formed of any suitably rigid,lightweight, and food-safe material, such as molded HDPE, e.g., moldedplastic.

The electronics compartment 714 is used to house the PCB assembly 112,wherein the PCB assembly 112 is not in contact with the medication inthe medication compartment 712. The battery compartment 716 is used tohouse one or more batteries (not shown) for supplying power to the PCBassembly 112, wherein the batteries are not in contact with themedication in the medication compartment 712. An access door or panel(not shown) can be provided in the electronics compartment 714 foraccessing the PCB assembly 112. Similarly, an access door or panel (notshown) can be provided in the battery compartment 716 for accessing theone or more batteries therein.

This embodiment of the data-enabled pharmaceutical container 100 is notlimited to that shown in FIG. 7. The integrated pharmaceutical container710 shown in FIG. 7 is exemplary only. The integrated pharmaceuticalcontainer 710 can take other shapes and sizes, such as, but not limitedto, the shapes and sizes shown in FIG. 5 and FIG. 6.

FIG. 8 illustrates a block diagram of an example of control electronics800 of the electronics module 110 of the data-enabled pharmaceuticalcontainer 100 for reminding at dose time, then detecting valid doseevents, as well as for processing and communicating information aboutvalid dose events and/or dose exception events (e.g., missed, extra,early, and late doses). The control electronics 800 is circuitry that isimplemented on the PCB 116. In this example, the control electronics 800includes a communications interface 810; a processor 812 that furtherincludes the patient's dosing regimen 814, a dose detection algorithm816, actual dose information 818, and optionally a security component820; a real-time clock 822; a momentary contact switch 824; a tiltsensor 826; and the one or more indicators 120. The components of thecontrol electronics 800 are powered by one or more batteries 828. Eachof the batteries 828 can be any standard cylindrical battery, such asquadruple-A, triple-A, or double-A, or a battery from the family ofbutton cell and coin cell batteries. A specific example of a battery 828may be the CR2032 coin cell 3-volt battery.

The communications interface 810 may be any wired and/or wirelesscommunication interface for connecting to a network (not shown) and bywhich information may be exchanged with other devices connected to thenetwork. Examples of wired communication interfaces may include, but arenot limited to, USB ports, RS232 connectors, RJ45 connectors, Ethernet,and any combinations thereof. Examples of wireless communicationinterfaces may include, but are not limited to, an Intranet connection,Internet, ISM, Bluetooth® technology, Wi-Fi, Wi-Max, IEEE 802.11technology, radio frequency (RF), Infrared Data Association (IrDA)compatible protocols, Local Area Networks (LAN), Wide Area Networks(WAN), Shared Wireless Access Protocol (SWAP), any combinations thereof,and other types of wireless networking protocols. Examples ofinformation facilitated by the communications interface 810 include thetransmission of the dosing regimen 814 and the actual dose information818. Other examples of information facilitated by the communicationsinterface 810 is the transmission of a “missed dose” alert, a “refill”alert, and an “extra dose” alert to the patient, to a caretaker, or toany other authorized party.

The processor 812 is used to manage the overall operations of thedata-enabled pharmaceutical container 100 with respect reminding at dosetime, then tracking and communicating valid dose events and/or doseexception events (e.g., missed, extra, early, and late doses). Theprocessor 812 can be any standard controller or microprocessor devicethat is capable of executing program instructions. A certain amount ofdata storage (not shown) may be associated with the processor 812. Inone example, the processor 812 is the PIC18LF14K50 Microcrontroller,available from Microchip Technology, Inc (Chandler, Ariz.).

Using the communications interface 810, a patient's dosing regimen 814can be loaded into the processor 812. The dosing regimen 814 can be anyinformation about the patient's prescribed medication and dosingregimen. In one example, the patient's dosing regimen 814 indicates one50-mg dose per day of levothroxine. In another example, the patient'sdosing regimen 814 indicates two 50-mg doses daily (e.g., one dose every12 hours) of levothroxine. In yet another example, the patient's dosingregimen 814 indicates three 50-mg doses daily of levothroxine (e.g., onedose upon waking, one mid-day dose, and one dose at bedtime).

The dose detection algorithm 816 that is programmed into the processor812 is used to detect valid dose events. For example, a dose event isdeemed valid based on (1) sensing the open state of the data-enabledpharmaceutical container 100 (e.g., sensing that the closure 156 is notpresent), (2) sensing a certain orientation or tilt (e.g., greater than90 degrees from vertical, or past horizontal) of the data-enabledpharmaceutical container 100, and (3) sensing that the data-enabledpharmaceutical container 100 is both opened and tilted simultaneouslyfor a certain amount of time (e.g., a few seconds). Using theaforementioned criteria, incidental movement of the data-enabledpharmaceutical container 100, such as the container falling over orbeing jostled in a computer bag or a purse, will not register by thedose detection algorithm 816 as a valid dose event.

With respect to sensing the open state of the data-enabledpharmaceutical container 100 (e.g., sensing that the closure 156 is notpresent), the lever 118 shown in FIG. 1 through FIG. 7 and shown in FIG.9 through FIG. 12D is engaged with the actuator (e.g., pushbutton) ofthe momentary contact switch 824. Together, the lever 118 and themomentary contact switch 824 provide the sensing mechanism fordetermining whether the data-enabled pharmaceutical container 100 isopened or closed. When the closure 156 is present and in contact withthe tip of the lever 118, a portion of the lever 118 is pushed againstthe actuator of the momentary contact switch 824, and the momentarycontact switch 824 is in one state (e.g., closed), as shown in FIG. 9.By contrast, when the closure 156 is not present and therefore not incontact with the tip of the lever 118, the lever 118 is not pushedagainst the actuator of the momentary contact switch 824, and themomentary contact switch 824 is in another state (e.g., open), as shownin FIG. 10. In one example, the momentary contact switch 824 is aside-actuated micro-switch, such as the SDS005 side-actuated detectswitch, available from ITT Corporation (White Plains, N.Y.).Accordingly, the state of the momentary contact switch 824 is one inputof the dose detection algorithm 816 that is used for detecting validdose events.

The data-enabled pharmaceutical container 100 is not limited to usingthe lever 118 and the momentary contact switch 824 for sensing whetherthe data-enabled pharmaceutical container 100 is opened or closed. Othermechanisms can be used, such as, but not limited to, the mechanismsdescribed with reference to U.S. Pat. No. 8,067,935, filed Jun. 5, 2008,entitled “System for sensing the opening and closing of a pharmaceuticalcontainer,” which is incorporated herein in its entirety. The '935patent describes multiple embodiments of mechanisms for sensing theopening and closing of pharmaceutical containers. In particular, The'935 patent describes sensing mechanisms that trigger an automatic,built-in, electronic dosage reminder and open/close event loggingoperation while requiring no additional actions or otherwise changedbehavior by the patient, in order to increase patient compliance withdosing regimens. In one embodiment, the sensing mechanism includes twoelectrical conductors that have no electrical connection therebetweenwhen the closure is not present on the container and a bridge conductorin the closure that provides an electrical connection therebetween whenthe closure is tightened onto the container. In this example embodiment,the state of the two electrical conductors may be monitored in order tosense a container opening and closing event.

The tilt sensor 826 is used for sensing orientation or tilt of thedata-enabled pharmaceutical container 100. A tilt sensor can measure thetilting in often two axes of a reference plane in two axes. In oneexample, the tilt sensor 826 is the SQ-SEN-390 on/off tilt sensor,available from SignalQuest, Inc (Lebanon, N.H.). The SQ-SEN-390 on/offtilt sensor acts like a position sensitive switch that is normallyclosed when below horizontal and normally open when above horizontal. Anexample of the tilt sensor 826 is shown in FIG. 11. With respect to thedata-enabled pharmaceutical container 100, when the container body 152is tilted beyond horizontal, e.g. past 90 degrees, the state of the tiltsensor 826 indicates that the container body 152 is in a position topotentially dispense (dump out) an oral dose form, such as a pill orcapsule. Accordingly, the state of the tilt sensor 826 is another inputof the dose detection algorithm 816 that is used for detecting validdose events.

The data-enabled pharmaceutical container 100 is not limited to usingthe SQ-SEN-390 on/off tilt sensor for sensing orientation or tilt. Othermechanisms can be used for sensing tilt, such as, but not limited to, anaccelerometer, an inertial measurement unit (IMU), and an inclinometer.Further, the data-enabled pharmaceutical container 100 is not limited tosensing orientation past 90 degrees. Less tilt than 90 degrees can bedetected as needed with the above noted mechanisms for sensing tilt forspecific uses, such as liquids, which may be dispensed from fullcontainers with, for example, 45 degrees of tilt.

With respect to sensing that the data-enabled pharmaceutical container100 is both opened and tilted simultaneously for a certain amount oftime (e.g., a few seconds), the internal clock of the processor 812 orthe real-time clock 822 can be used. For example, upon sensing both thatthe closure 156 is not present and a tilt below horizontal, the internalclock of the processor 812 or the real-time clock 822 is used to measurethe amount of time that both conditions are simultaneously present. Ifboth conditions are present at the same time for, for example, about 3seconds, then the dose detection algorithm 816 logs the date and time ofa valid dose event in the actual dose information 818. Accordingly, thetime of both conditions being present is yet another input of the dosedetection algorithm 816 that is used for detecting valid dose events.Any valid dose events that are detected via dose detection algorithm 816are logged in the actual dose information 818. For example, the date andtime of the dose event is logged in the actual dose information 818.More details of an example of a method of detecting a valid dose eventare described with reference to FIG. 13.

Additionally, the processor 812 and/or the dose detection algorithm 816can be programmed to compare valid dose events that are detected toinformation stored in the patient's dosing regimen 814. In so doing, itcan be determined whether the prescribed dosing regimen is beingfollowed. Namely, using the patient's dosing regimen 814, it can bedetermined whether doses have been taken on time, whether doses havebeen missed, whether extra doses have been taken, whether early doseshave been taken, and whether late doses have been taken. Additionally,using the patient's dosing regimen 814, the processor 812 and/or thedose detection algorithm 816 can be used to activate reminder indicatorsand any other types of indicators. Namely, the real-time clock 822provides a calendar and time of day function that can be used with thedosing regimen 814 in order to determine whether doses have been takenon time, whether doses have been missed, whether extra doses have beentaken, whether early doses have been taken, and whether late doses havebeen taken, and to generate reminders. An example of the real-time clock822 is the S-35390A, 2-wire CMOS real-time clock, available from SeikoInstruments, Inc (Torrance, Calif.).

The security component 820 in the processor 812 can be any softwaremodule that is used to perform any security functions with respect tokeeping the contents of, for example, the dosing regimen 814 and theactual dose information 818 secure. For example, the security component820 may use standard security techniques, such as encryption, securehashtags (or hash tags), and the like. For example, the securitycomponent 820 can be used to decrypt the dosing regimen 814, which maybe received encrypted. Additionally, the security component 820 can beused to encrypt the actual dose information 818 when transmitted viacommunications interface 810. However, the use of encryption in thedata-enabled pharmaceutical container 100 is optional.

The one or more indicators 120 are used to convey information to thepatient or caretaker in response to the information processed viaprocessor 812 and/or the dose detection algorithm 816. Further, thetime-stamped states of any of the indicators 120 can also be logged inthe actual dose information 418. In one example, the indicators 120 arelight-emitting diode (LED) devices. For example, four indicators 120 maybe provided—a green “TAKE” LED, a light green “TAKEN” LED, a red“MISSED” LED, and a yellow “ORDER REFILL” LED. Openings (not shown) canbe provided in the housing 114 and/or in the sleeve or label 158 of thedata-enabled pharmaceutical container 100 that allow the indicators 120to be visible. Further, TAKE, TAKEN, MISSED, and ORDER REFILL can beprinted on the sleeve or label 158 corresponding to the four indicators120.

The green “TAKE” LED is used for prompting the user to take theprescribed dose of medication. For example, the information containedwithin the dosing regimen 814 may indicate a patient should take onedose at 4:00 pm daily. When the real-time clock 822 indicates thecurrent time to be about 4:00 pm, the processor 812 activates the “TAKE”LED. In another example, if the dosing regimen 814 indicates 2 dosesdaily, 12 hours apart, then the “TAKE” LED may be activated about 12hours after the previously detected valid dose event.

Upon detecting a valid dose event via dose detection algorithm 816, the“TAKE” LED is deactivated and the light green TAKEN″ LED is activated.Namely, the “TAKEN” LED indicates that a valid dose event has occurredas detected via dose detection algorithm 816. For example, if allcriteria of the dose detection algorithm 816 are met, the processor 812activates the “TAKEN” LED. After the valid dose event is detected, the“TAKEN” LED may remain activated (e.g., continues to flash) for someperiod of time (e.g., an hour or until the next dose time).

The red “MISSED” LED indicates a user has not taken the dose ofmedication in accordance to the dosing regimen 814. Using the real-timeclock 822, the processor 812 may be programmed to activate the “MISSED”LED, for example, one hour past the scheduled dose time. For example,the information contained within the dosing regimen 814 may indicate apatient should take one dose at 4:00 pm daily. In this example, when thereal-time clock 822 indicates the current time is 5:00 pm and a doseevent has not recently been detected via dose detection algorithm 816,the processor 812 activates the “MISSED” LED. The “MISSED” LED mayremain activated for a predetermined period of time (e.g., 1 hour) oruntil the “TAKE” LED is next activated. Additionally, using thecommunications interface 810, a “missed dose” alert can be transmittedto the patient, caretaker, or any other authorized party.

The yellow “ORDER REFILL” LED indicates the bottle is nearly out ofmedication and a prescription refill is needed. For example a patient'sdosing regiment may require one dose per day for 30 days. Therefore, aninitial fill of medication is 30 pills. The total number of pillscontained within the data-enabled pharmaceutical container 100 (e.g., 30pills) is indicated in the dosing regimen 814. The processor 812 cancount the number of valid dose events logged in the actual doseinformation 818 and determine how many doses presently remain in thedata-enabled pharmaceutical container 100. In addition to dose count,the processor 812 uses real-time clock 822 to verify that, for example,at least 25 days have passed since the last refill (for a 30-dayprescription), as health insurance companies typically will notauthorize monthly refills until 25 days have passed since the lastrefill (for a 30-day prescription). In another example, for a 90-dayprescription, the time period may be 85 days. Once the number of dosesis nearly depleted (e.g., 5 doses remaining) and the prescribed numberof days have passed (e.g., 25 days or 85 days), the processor 812activates the “ORDER REFILL” LED to indicate that a refill is needed.Additionally, using the communications interface 810, a “refill” alertcan be transmitted to the patient, caretaker, or any other authorizedparty.

FIG. 9 and FIG. 10 illustrate plan views of the side of the PCB assembly112 that is oriented toward the container body 152 and showing the lever118 in two different positions. Namely, FIG. 9 shows the position of thelever 118 when the closure 156 is secured on the container neck 154 andpushing against the tip of the lever 118. In so doing, a portion of thelever 118 presses against the actuator of the momentary contact switch824. By contrast, FIG. 10 shows the position of the lever 118 when theclosure 156 is not present and therefore not pushing against the tip ofthe lever 118. In this state, the lever 118 is not pressed against theactuator of the momentary contact switch 824. FIG. 9 corresponds to thedata-enabled pharmaceutical container 100 in the closed state. FIG. 10corresponds to the data-enabled pharmaceutical container 100 in theopened state. The lever 118 moves about a pivot point 910. Together, thelever 118 and the momentary contact switch 824 provide the sensingmechanism for determining whether the data-enabled pharmaceuticalcontainer 100 is opened or closed.

Further to the example, FIG. 11 shows a plan view of the side of the PCBassembly 112 that is oriented away from the container body 152. LikeFIG. 9, FIG. 11 corresponds to the data-enabled pharmaceutical container100 in the closed state. Also shown in FIG. 11 is an example of the tiltsensor 826. However, the tilt sensor 826 is not limited to mounting onthis side of the PCB 116. The tilt sensor 826 can be mounted on eitherside of the PCB 116.

FIG. 12A and FIG. 12B illustrate a perspective view and a back view,respectively, of an example of the lever 118. The lever 118 is formed ofany suitably rigid, lightweight, and food-safe material, such as moldedHDPE, e.g., molded plastic. The lever 118 may be made by, for example,injection molding. For example, the lever 118 is a substantiallyL-shaped member that includes an elbow 1210. One end of the L-shapedmember may include a snap-fitting 1212 for securing the lever 118 to thePCB 116 in a pivoting fashion. Namely, the snap-fitting 1212 may bedesigned to be press-fitted into a hole in the PCB 116 and provides thepivot point 910 shown in FIG. 9, FIG. 10, and FIG. 11. The other end ofthe L-shaped member may include a protrusion 1214, which is the tip ofthe lever 118 that comes into contact with the closure 156 when in use.The lever 118 can be modified in any manner to allow the lever tonegotiate the shoulder or shoulders of the container body 152 of thedata-enabled pharmaceutical container 100. Namely, to be positionedunder the closure 156 in order to toggle from one position to anotherdepending on whether the data-enabled pharmaceutical container 100 isopened or closed. More particularly, the shape of the lever 118 can betailored to correspond to the shape of the pharmaceutical container withwhich it is used as long as the tip of the lever 118 can come intocontact with the closure thereof when closed.

FIG. 13 illustrates a flow diagram of an example of a method 1300 ofdetermining a valid dose event using the data-enabled pharmaceuticalcontainer 100. The method 1300 may include, but is not limited to, thefollowing steps.

At a step 1310, the processor 812 and/or the dose detection algorithm816 monitor dose event criteria in order to detect valid dose events,track valid dose events, and communicate information about valid doseevents and/or dose exception events. For example, the processor 812and/or the dose detection algorithm 816 continuously monitor the stateof the momentary contact switch 824, the state of the tilt sensor 826,the calendar date and time of the real-time clock 822; all in relationto the patient's dosing regimen 814.

At a decision step 1312, the processor 812 and/or the dose detectionalgorithm 816 determine whether the data-enabled pharmaceuticalcontainer 100 is opened, meaning whether the closure 156 is not securedto the data-enabled pharmaceutical container 100. Namely, the state ofthe momentary contact switch 824 indicates whether the closure 156 issecured or not secured to the data-enabled pharmaceutical container 100.In one example, if the momentary contact switch 824 is a normally openmomentary contact switch, when the closure 156 is present and pressedagainst the tip of the lever 118, the momentary contact switch 824 isactuated and in the closed state. In this example, the momentary contactswitch 824 in the closed state means that the data-enabledpharmaceutical container 100 is closed. By contrast, when the closure156 is not present and not pressed against the tip of the lever 118, themomentary contact switch 824 is not actuated and in the open state. Inthis example, the momentary contact switch 824 in the open state meansthat the data-enabled pharmaceutical container 100 is opened. If it isdetermined that the data-enabled pharmaceutical container 100 is opened,the method 1300 proceeds to a step 1314. However, if it is determinedthat the data-enabled pharmaceutical container 100 is not opened, thenthe method 1300 returns to step 1310.

At a decision step 1314, the processor 812 and/or the dose detectionalgorithm 816 determine whether the tilt criterion of the data-enabledpharmaceutical container 100 has been met for a valid dose event. In oneexample the tilt criterion is greater than 90 degrees from vertical, orpast horizontal. Namely, the state of the tilt sensor 826 indicateswhether the data-enabled pharmaceutical container 100 is tilted enoughto cause a pill or capsule to dispense from the container body 152. Inone example, when the tilt sensor 826 is oriented substantially verticalits switch is open, which means that the data-enabled pharmaceuticalcontainer 100 is not tilted enough to cause a pill or capsule todispense from the container body 152. By contrast, when the tilt sensor826 is oriented greater than 90 degrees from vertical or past horizontalits switch is closed, which means that the data-enabled pharmaceuticalcontainer 100 is tilted enough to cause a pill or capsule to dispensefrom the container body 152. If it is determined that the tilt criterionof the data-enabled pharmaceutical container 100 has been met for avalid dose event, the method 1300 proceeds to a step 1316. However, ifit is determined that the tilt criterion of the data-enabledpharmaceutical container 100 has not been met for a valid dose event,then the method 1300 returns to step 1310.

At a decision step 1316, the processor 812 and/or the dose detectionalgorithm 816 determine whether the time criterion of the data-enabledpharmaceutical container 100 has been met for a valid dose event. Forexample, upon sensing both that the data-enabled pharmaceuticalcontainer 100 is opened in step 1312 and that the tilt criterion is metin step 1314, the internal clock of the processor 812 or the real-timeclock 822 is used to measure the amount of time that both conditions aresimultaneously present. If both conditions are present at the same timefor a predetermined amount of time, then the method 1300 proceeds tostep 1318. The predetermined amount of time can be from about 2 secondsto about 5 seconds in one example, or is about 3 seconds in anotherexample. However, if both conditions are not met at the same time forthe prescribed length of time, then a valid dose event is not detectedand the method 1300 returns to step 1310.

At a step 1318, a valid dose event is logged. Any valid dose events thatare detected via dose detection algorithm 816 are logged in the actualdose information 818. For example, the date and time of the dose eventis logged in the actual dose information 818.

FIG. 14 illustrates a flow diagram of an example a method 1400 ofoperation of the data-enabled pharmaceutical container 100. Namely, themethod 1400 is a method of using the data-enabled pharmaceuticalcontainer 100 for reminding at dose time, then tracking andcommunicating valid dose events and/or dose exception events (e.g.,missed, extra, early, and late doses). The method 1400 may include, butis not limited to, the following steps.

At a step 1410, the data-enabled pharmaceutical container 100 isprepared for use. For example, using the communications interface 810, amedical or pharmaceutical professional, or other qualified party, mayconnect, either wired and/or wirelessly, the data-enabled pharmaceuticalcontainer 100 to a computer (not shown) for programming and exchange ofinformation between the computer and the data-enabled pharmaceuticalcontainer 100. For example, using the communications interface 810, thepatient's dosing regimen 814 may be loaded into the processor 812,updates may be loaded into the dose detection algorithm 816, thereal-time clock 822 may be set or reset, the health status of battery828 may be checked, and the like. Further, the data-enabledpharmaceutical container 100 is filled with the prescribed medication,labeled, and physically conveyed to the patient for use. The method 1400proceeds to step 1412.

At a step 1412, the processor 812 and/or the dose detection algorithm816 monitor dose event criteria and medication adherence continuously orat specified intervals. For example, the processor 812 receives andinterprets information from the dosing regimen 814, the dose detectionalgorithm 816, the real-time clock 822, whether and when valid doseevents occur and whether they are in compliance with/adherent toprescribed dosing instructions stored in the dosing regimen 814.Further, at any time, the patient can visually monitor the indicators120 to see whether any action is required, such as whether it is time totake a dose, whether a dose has been missed, whether it is time for aprescription refill, and the like. The method 1400 proceeds to step1414.

At an optional step 1414, encrypted or unencrypted the actual doseinformation 818 is transmitted to an external computing device using thecommunications interface 810. Namely, at any time during the method1300, any information at the data-enabled pharmaceutical container 100can be interrogated using the communications interface 810. The method1400 proceeds to step 1416.

At a step 1416, any previously activated indicators 120 are deactivated,the “TAKE” LED is activated according to the dosing regimen 814, andthis event is logged in the actual dose information 818. Optionally,using the communications interface 810, a “take dose” alert can betransmitted to the patient or any other caretaker or authorized partythat it is time to take the dose. The method 1400 proceeds to step 1418.

At a decision step 1418, it is determined whether a valid dose event hasoccurred according to the method 1300. If it is determined that a validdose event has occurred, the method 1400 proceeds to step 1422. However,if it is determined that a valid dose event has not occurred within theprescribed period of time (e.g., within ±2 hours of the prescribedtime), then the method 1400 proceeds to step 1420.

At a step 1420, any previously activated indicators 120 are deactivated,the “MISSED” LED is activated, and this event is logged in the actualdose information 818. Optionally, using the communications interface810, a “missed dose” alert can be transmitted to the patient or anyother caretaker or authorized party that the dose has been missed. Themethod 1400 returns to step 1418.

At a step 1422, once a valid dose event has been detected according tothe method 1300, any previously activated indicators 120 aredeactivated, the “TAKEN” LED is activated, and this event is logged inthe actual dose information 818. Optionally, using the communicationsinterface 810, a “dose taken” alert can be transmitted to the patient,the pharmacy, or any other caretaker or authorized party. The method1400 proceeds to both step 1424 and step 1428.

At a decision step 1424, it is determined whether a prescription refillis needed. For example, the processor 812 can count the number of validdose events logged in the actual dose information 818 and determine howmany doses presently remain in the data-enabled pharmaceutical container100. In addition to dose count, the processor 812 uses real-time clock822 to verify that, for example, at least 25 days have passed since thelast refill (for a 30-day prescription), as health insurance companiestypically will not authorize monthly refills until 25 days have passedsince the last refill (for a 30-day prescription). In another example,for a 90-day prescription, the time period may be 85 days. If theprocessor 812 determines that the number of doses is nearly depleted(e.g., 5 doses remaining) and the prescribed number of days have passed(e.g., 25 days or 85 days), then method a prescription refill is neededand the method 1400 proceeds to step 1426. However, if the processor 812determines that the number of doses is not nearly depleted (e.g.,greater than 5 doses remaining) or that the prescribed number of dayshave not passed, then a prescription refill is not needed and the method1400 returns to step 1412.

At a step 1426, any previously activated indicators 120 are deactivated,the “ORDER REFILL” LED is activated, and this event is logged in theactual dose information 818. Optionally, using the communicationsinterface 810, a “refill” alert can be transmitted to the patient, thepharmacy, or any other caretaker or authorized party. The method 1400returns to step 1412.

At a decision step 1428, it is determined whether an extra dose eventhas occurred according to the method 1300 and according to the dosingregimen in the patient's dosing regimen 814. If it is determined that anextra dose event has occurred, the method 1400 proceeds to step 1430.However, if it is determined that an extra dose event has not occurredwith respect to the dosing regimen in the patient's dosing regimen 814,then the method 1400 returns to step 1412.

At a step 1430, the extra dose event is logged in the actual doseinformation 818. Optionally, using the communications interface 810, an“extra dose” alert can be transmitted to the patient, the pharmacy, orany other caretaker or authorized party. Optionally, the electronicsmodule 110 can include an EXTRA DOSE LED that is activated in this step.The method 1400 returns to step 1412.

Table 1 below shows an example of a record of data in the actual doseinformation 818 that can be compiled using the method 1300 of FIG. 13and/or the method 1400 of FIG. 14. In the example shown in Table 1, therecord of data is for one calendar day.

TABLE 1 Example record of data in the actual dose information 818 forJul. 12, 2013 Patient Name: John Doe Patient Address: 487 Elm St,Scranton, PA 18505 RX # 0569790-07365 Medication: LEVOTHROXINE Dose: Two50-mg doses daily Timestamp Data Event Data 12-Jul-2013; 06:35:15.2“TAKE” LED activated 12-Jul-2013; 07:35:15.2 “MISSED” LED activated12-Jul-2013; 07:51:15.7 Valid dose event detected, “MISSED” LEDdeactivated, “TAKEN” LED activated 12-Jul-2013; 08:51:15.7 “TAKEN” LEDdeactivated 12-Jul-2013; 19:51:15.7 “TAKE” LED activated 12-Jul-2013;20:34:15.4 Valid dose event detected, “TAKE” LED deactivated, “TAKEN”LED activated 12-Jul-2013; 21:34:15.4 “TAKEN” LED deactivated

While the example shown in Table 1 is a record of data is for onecalendar day, the actual dose information 818 can include any number ofrecords, for any number of days. For example, Table 2 below shows anexample of a summary report for a 30-day period, wherein the summaryreport is compiled using information in the actual dose information 818.Table 2 also shows the percent medication adherence for the patient forthe 30-day period.

TABLE 2 Example summary report for a 30-day period Patient Name: JohnDoe Patient Address: 487 Elm St, Scranton, PA 18505 RX # 0569790-07365Medication: LEVOTHROXINE Start: Jun. 15, 2013 Duration: 30 days Dose:One 50-mg dose daily Dose Time: 08:00 ±2 hours Summary: Taken = 24doses, Missed = 6 doses, Adherence = 80% Day Date Time Status SaturdayJun. 15, 2013 07:58 Taken Sunday Jun. 16, 2013 09:05 Taken Monday Jun.17, 2013 10:01 Missed Monday Jun. 17, 2013 13:05 Late Tuesday Jun. 18,2013 06:30 Taken Wednesday Jun. 19, 2013 08:15 Taken Thursday Jun. 20,2013 07:45 Taken Friday Jun. 21, 2013 07:51 Taken Saturday Jun. 22, 201310:01 Missed Sunday Jun. 23, 2013 10:01 Missed Monday Jun. 24, 201310:01 Missed Tuesday Jun. 25, 2013 08:30 Taken Wednesday Jun. 26, 201306:15 Taken Wednesday Jun. 26, 2013 09:37 Extra Thursday Jun. 27, 201307:32 Taken Friday Jun. 28, 2013 07:34 Taken Saturday Jun. 29, 201308:12 Taken Sunday Jun. 30, 2013 09:15 Taken Monday Jul. 1, 2013 09:57Taken Tuesday Jul. 2, 2013 07:25 Taken Wednesday Jul. 3, 2013 09:21Taken Thursday Jul. 4, 2013 07:43 Taken Friday Jul. 5, 2013 08:09 TakenSaturday Jul. 6, 2013 05:44 Early Saturday Jul. 6, 2013 10:01 MissedSunday Jul. 7, 2013 07:19 Taken Monday Jul. 8, 2013 10:01 Missed TuesdayJul. 9, 2013 10:01 Missed Wednesday Jul. 10, 2013 10:01 Missed ThursdayJul. 11, 2013 07:34 Taken Friday Jul. 12, 2013 08:42 Taken Saturday Jul.13, 2013 09:48 Taken Sunday Jul. 14, 2013 09:01 Taken

Referring now to FIG. 15 and FIG. 16 are perspective views of an exampleof a data-enabled pharmaceutical sleeve 1500 into which a conventionalpharmaceutical container (e.g., the pharmaceutical container 150 shownin FIG. 5) is installed, wherein the data-enabled pharmaceutical sleeve1500 includes the PCB assembly 112.

In this example, the data-enabled pharmaceutical sleeve 1500 includes asleeve body 1510 that further includes a cavity 1512, an electronicscompartment 1514, and optionally a battery compartment 1516. The cavity1512 can be sized and shaped to receive any conventional pharmaceuticalcontainer. The data-enabled pharmaceutical sleeve 1500 may be formed ofany suitably rigid, lightweight, and food-safe material, such as moldedHDPE, e.g., molded plastic. The electronics compartment 1514 is used tohouse the PCB assembly 112. The battery compartment 1516 is used tohouse one or more batteries (not shown) for supplying power to the PCBassembly 112. An access door or panel (not shown) can be provided in theelectronics compartment 1514 for accessing the PCB assembly 112.Similarly, an access door or panel (not shown) can be provided in thebattery compartment 1516 for accessing the one or more batteriestherein.

In the example shown in to FIG. 15 and FIG. 16, the cavity 1512 is sizedand shaped to receive the pharmaceutical container 150 shown in FIG. 5.Namely, FIG. 15 shows the pharmaceutical container 150 prior to fittinginto the cavity 1512 of the data-enabled pharmaceutical sleeve 1500,while FIG. 16 shows the pharmaceutical container 150 fitted into thecavity 1512 of the data-enabled pharmaceutical sleeve 1500. The cavity1512 is sized and shaped so that the pharmaceutical container 150 isfitted snuggly therein. Additionally, the cavity 1512 is sized andshaped so that the closure 156 of the pharmaceutical container 150 is incontact with the lever 118 when present atop the container body 152.Further, the closure 156 is not in contact with the lever 118 when notpresent atop the container body 152.

Together, the data-enabled pharmaceutical sleeve 1500 and theconventional pharmaceutical container (e.g., the pharmaceuticalcontainer 150 shown in FIG. 5) provide substantially the samefunctionality as the data-enabled pharmaceutical container 100 describedwith reference to FIG. 1 through FIG. 14. Namely, the data-enabledpharmaceutical sleeve 1500 includes the same PCB assembly 112 andcontrol electronics 800 as the data-enabled pharmaceutical container 100and operates according to the method 1300 of FIG. 13 and the method 1400of FIG. 14.

Following long-standing patent law convention, the terms “a,” “an,” and“the” refer to “one or more” when used in this application, includingthe claims. Thus, for example, reference to “a subject” includes aplurality of subjects, unless the context clearly is to the contrary(e.g., a plurality of subjects), and so forth.

Throughout this specification and the claims, the terms “comprise,”“comprises,” and “comprising” are used in a non-exclusive sense, exceptwhere the context requires otherwise. Likewise, the term “include” andits grammatical variants are intended to be non-limiting, such thatrecitation of items in a list is not to the exclusion of other likeitems that can be substituted or added to the listed items.

For the purposes of this specification and appended claims, unlessotherwise indicated, all numbers expressing amounts, sizes, dimensions,proportions, shapes, formulations, parameters, percentages, parameters,quantities, characteristics, and other numerical values used in thespecification and claims, are to be understood as being modified in allinstances by the term “about” even though the term “about” may notexpressly appear with the value, amount or range. Accordingly, unlessindicated to the contrary, the numerical parameters set forth in thefollowing specification and attached claims are not and need not beexact, but may be approximate and/or larger or smaller as desired,reflecting tolerances, conversion factors, rounding off, measurementerror and the like, and other factors known to those of skill in the artdepending on the desired properties sought to be obtained by thepresently disclosed subject matter. For example, the term “about,” whenreferring to a value can be meant to encompass variations of, in someembodiments, ±100% in some embodiments ±50%, in some embodiments ±20%,in some embodiments ±10%, in some embodiments ±5%, in some embodiments±1%, in some embodiments ±0.5%, and in some embodiments ±0.1% from thespecified amount, as such variations are appropriate to perform thedisclosed methods or employ the disclosed compositions.

Further, the term “about” when used in connection with one or morenumbers or numerical ranges, should be understood to refer to all suchnumbers, including all numbers in a range and modifies that range byextending the boundaries above and below the numerical values set forth.The recitation of numerical ranges by endpoints includes all numbers,e.g., whole integers, including fractions thereof, subsumed within thatrange (for example, the recitation of 1 to 5 includes 1, 2, 3, 4, and 5,as well as fractions thereof, e.g., 1.5, 2.25, 3.75, 4.1, and the like)and any range within that range.

The foregoing detailed description of embodiments refers to theaccompanying drawings, which illustrate specific embodiments of theinvention. Other embodiments having different structures and operationsdo not depart from the scope of the present invention. The term “theinvention” or the like is used with reference to certain specificexamples of the many alternative aspects or embodiments of theapplicant's invention set forth in this specification, and neither itsuse nor its absence is intended to limit the scope of the applicant'sinvention or the scope of the claims. This specification is divided intosections for the convenience of the reader only. Headings should not beconstrued as limiting of the scope of the invention. The definitions areintended as a part of the description of the invention. It will beunderstood that various details of the present invention may be changedwithout departing from the scope of the present invention. Furthermore,the foregoing description is for the purpose of illustration only, andnot for the purpose of limitation, as the present invention is definedby the claims as set forth hereinafter.

We claim:
 1. A method of determining a valid dose event using adata-enabled pharmaceutical container, the method comprising: a)providing a data-enabled pharmaceutical container comprising: i) apharmaceutical container comprising 1.) a container body; 2.) acontainer neck; and 3.) a container closure, wherein the container bodyis configured as a reservoir for holding a quantity of medication, thecontainer neck comprises an opening for dispensing the medication fromthe container body, and wherein the container closure is configured tosecure the container neck opening; and ii) an electronics moduleconfigured for sensing and tracking dose events coupled to thepharmaceutical container, wherein the electronics module comprises ahousing, one or more indicators, one or more switches, and one or moresensors, and wherein one of the one or more sensors comprises a movablelever, and wherein the movable lever extends through an opening in thehousing and toward the container neck, wherein the movable lever is partof a mechanism for sensing whether the container closure is present ator absent from the container neck, and wherein the movable lever isconfigured such that when the container closure is present on thecontainer neck an edge of the container closure is in contact with a tipof the movable lever causing the movable lever to be in a firstposition, and when the container closure is not present on the containerneck the edge of the container closure does not contact the tip of themovable lever causing the movable lever to be in a second position; b)monitoring the data-enabled pharmaceutical container for pre-definedvalid dose event criteria; c) determining whether the data-enabledpharmaceutical container has met the pre-defined criteria for the validdose event; and d) recording the valid dose event upon determining thepre-defined criteria for the valid dose event is met.
 2. The method ofclaim 1 wherein the electronics module comprises a printed circuit board(PCB) assembly housed within the housing, the PCB assembly comprising aPCB.
 3. The method of claim 1 wherein determining whether thedata-enabled pharmaceutical container has met the pre-defined criteriafor the valid dose event comprises one or more of determining if thedata-enabled pharmaceutical container is in an opened state, determiningwhether the data-enabled pharmaceutical container has met a defined tiltcriteria, and determining whether the data-enabled pharmaceutical hasmet a defined time criteria.
 4. The method of claim 3 wherein thepre-defined criterion for the valid dose event comprises thedata-enabled pharmaceutical container being in an opened state and thedata-enabled pharmaceutical container exceeding a defined tilt thresholdcriterion for a defined period of time.
 5. The method of claim 1 furthercomprising detecting, tracking, and communicating data regarding validdose events and/or dose exception events.
 6. The method of claim 1wherein monitoring the data-enabled pharmaceutical container forpre-defined valid dose event criteria comprises, the electronics modulecontinuously monitoring the state of the one or more switches andsensors, and time of a real-time clock in relation to a patient'sdefined dosing regimen.
 7. The method of claim 1 further comprisingdetecting, tracking, and communicating data regarding a patient's actualdose information.
 8. A method of using a data-enabled pharmaceuticalcontainer for reminding at dose time, then tracking and communicatingvalid dose events and/or dose exception events, the method comprising:a) preparing the data-enabled pharmaceutical container for use whereinthe data-enabled pharmaceutical container comprises: i) a pharmaceuticalcontainer comprising 1.) a container body; 2.) a container neck; and 3.)a container closure, wherein the container body is configured as areservoir for holding a quantity of medication, the container neckcomprises an opening for dispensing the medication from the containerbody, and wherein the container closure is configured to secure thecontainer neck opening; and ii) an electronics module configured forsensing and tracking dose events coupled to the pharmaceuticalcontainer, wherein the electronics module comprises a housing, one ormore indicators, one or more switches, and one or more sensors, andwherein one of the one or more sensors comprises a movable lever, andwherein the movable lever extends through an opening in the housing andtoward the container neck, wherein the movable lever is part of amechanism for sensing whether the container closure is present at orabsent from the container neck, and wherein the movable lever isconfigured such that when the container closure is present on thecontainer neck an edge of the container closure is in contact with a tipof the movable lever causing the movable lever to be in a firstposition, and when the container closure is not present on the containerneck the edge of the container closure does not contact the tip of themovable lever causing the movable lever to be in a second position; b)monitoring valid dose event criteria and medication adherence; c)determining whether a valid dose event has occurred; and d) recordingactual dose event data.
 9. The method of claim 8 wherein preparing thedata-enabled pharmaceutical container for use comprises one or more ofprogramming a patient's dosing regimen into a processor of thedata-enabled pharmaceutical container; loading updates into theprocessor of the data-enabled pharmaceutical container; retrievingstored dose event data; setting or resetting a real-time clock of thedata-enabled pharmaceutical container; checking diagnostics of thedata-enabled pharmaceutical container; filling the data-enabledpharmaceutical container with medication; and labeling the data-enabledpharmaceutical container.
 10. The method of claim 9 wherein monitoringvalid dose event criteria and medication adherence comprises theprocessor receiving and interpreting data from one or more of thepatient's dosing regimen; a dose detection algorithm; the real-timeclock; whether and when valid dose events occur and whether they are incompliance with/adherent to dosing instructions stored in the patient'sdosing regimen.
 11. The method of claim 10 wherein the one or moreindicators are capable of being monitored by the patient.
 12. The methodof claim 11 wherein the one or more indicators are one or more of visualand audible.
 13. The method of claim 11 wherein the one or moreindicators are configured to indicate to the patient at least one of,time to take a dose, a dose has been missed, and time for a prescriptionrefill.
 14. The method of claim 8 further comprising transmitting datafrom the data-enabled pharmaceutical container to an external computingdevice using a communications interface.
 15. The method of claim 11further comprising following an actual dose event, deactivating anypreviously activated indicators and activating an applicable indicatoraccording to the patient's dosing regimen and recording the actual doseevent data.
 16. The method of claim 14 wherein data from thedata-enabled pharmaceutical container is transmitted to one or more ofthe patient, caretaker, and an authorized party via the communicationsinterface.
 17. The method of claim 15 wherein if the recorded actualdose event is a missed dose event according to the patient's dosingregimen the one or more indicators indicate a missed dose, and if therecorded actual dose event is a valid dose event according to thepatient's dosing regimen the one or more indicators indicate a takendose, and the applicable actual dose event is recorded.
 18. The methodof claim 8 further comprising determining whether a prescription refillis needed based on a number of valid dose events as compared to therecorded actual dose data and the patient's dosing regimen.
 19. Themethod of claim 18 wherein if it is determined a prescription refill isneeded the one or more indicators indicate a prescription refill isneeded.
 20. The method of claim 19 wherein a prescription refill noticeis sent to one or more of the patient, a pharmacy, and any othercaretaker or authorized party via a communications interface.